Saturday, 31 October 2020

Selecting the best surface disinfectants against COVID-19


COVID-19 continues to have a global impact, with infection numbers and mortality rates still reported daily. As a profession, dentistry is classified as being at high risk for the transmission of COVID-19, as the main routes of viral transmission are encountered routinely in dental practice. On 24th March, dental practices in the UK closed as part of a temporary lockdown.

In this article, Dr Tim Sandle, a microbiologist, examines which surface disinfectants are likely to be of particular benefit to dental practices, aiming to ensure the highest standards of IPC are met.

Sandle, T. (2020) Selecting the best surface disinfectants against COVID-19, Dental Nursing, 1st July 2020, at: https://www.dental-nursing.co.uk/features/robust-infection-prevention

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Friday, 30 October 2020

FDA issues mutagens guidance


 

ICH M7 Guideline: assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk- Q&A FDA has now formally published this Q&A as draft guidance for comment by 27 Nov.2020.

Since the ICH M7 Guideline was finalized, worldwide experience with implementation of the recommendations for DNA reactive (mutagenic) impurities has given rise to requests for clarification relating to the assessment and control of DNA reactive (mutagenic) impurities.

This Question and Answer (Q&A) document is intended to provide additional clarification and to promote convergence and improve harmonization of the considerations for assessment and control of DNA reactive (mutagenic) impurities and of the information that should be provided during drug development, marketing authorization applications and/or Master Files.

The scope of this Q&A document follows that of ICH M7.

See: https://www.fda.gov/media/142466/download 

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Thursday, 29 October 2020

MHRA and new Brexit rules



 

From 1 January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK’s standalone medicines and medical devices regulator. Transition from the EU allows the UK to offer fully independent regulatory decisions for both devices and pharmaceuticals, both nationally and in joint work with other international regulators.

Stakeholders need to get ready for new rules from 1 January 2021. See: https://www.gov.uk/government/collections/mhra-post-transition-period-information 

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Wednesday, 28 October 2020

MHRA joins new body

 


As part of post Brexit arrangements, the MHRA has joined the Australia-Canada-Singapore-Switzerland Consortium of regulators.

The consortium will change its name to the Access Consortium.

According to the press release, Access Consortium partners will work together with the primary aim of providing patients across the five countries with timely access to high quality, safe, and effective therapeutic products. Through the addition of the UK, the new combined population to be covered by the consortium is approximately 145 million people.

Any pharmaceutical companies submitting applications to some, or all, of the consortium member countries will benefit from having products evaluated for marketing in Access countries simultaneously with reduced evaluation times. Additionally, the Access Consortium will update the guidance for industry on how product applications may be considered for marketing authorization across the five countries, Australia, Canada, Singapore, Switzerland, and the UK. Is this of advantage to BPL?

MHRA press release link: https://www.gov.uk/government/news/uk-medicines-regulator-joins-up-with-australia-canada-singapore-and-switzerland-regulators

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